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Home-based Exercise in COVID-19 Survivors

10. Juni 2022 aktualisiert von: Bruno Gualano, University of Sao Paulo

Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial

The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Bruno Gualano, PhD
  • Telefonnummer: 8021 55112661
  • E-Mail: gualano@usp.br

Studienorte

  • Brasilien
      • Sao Paulo, Brasilien, 05508-030
        • Rekrutierung
        • University of Sao Paulo

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients diagnosed with COVID-19
  • Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
  • Admitted in intensive care unit

Exclusion Criteria:

  • Cardiovascular disease
  • Resting dyspnea
  • Acute pulmonary embolism or pulmonary infarction
  • Deep venous thromboembolism
  • Uncontrolled visual or vestibular disorders
  • Pregnancy
  • Uncontrolled resting tachycardia
  • Uncontrolled hypertension
  • Uncontrolled Type II diabetes
  • Acute infections
  • Neurological disorders
  • Patients with chronic kidney disease who are in need of hemodialysis
  • Recent malignant neoplasm (<5 years)
  • Autoimmune diseases
  • Complex ventricular arrhythmias, atrial fibrillation or complete heart block
  • Transplant patients
  • Any physical disabilities that could hamper physical testing and exercise program

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Übungsgruppe
Sonstiges: Exercise training
A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.
Kein Eingriff: Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means better outcome.
Baseline and 16 weeks.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Fasting serum concentrations of glucose and insulin.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Zeitfenster: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Zeitfenster: Baseline and one year.
Higher score means better outcome.
Baseline and one year.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Zeitfenster: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at one year.
Zeitfenster: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Zeitfenster: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Zeitfenster: Baseline and one year.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Zeitfenster: Baseline and one year.
Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Zeitfenster: Baseline and one year.
Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Zeitfenster: Baseline and one year.
Baseline and one year.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Sao Paulo

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. September 2020

Primärer Abschluss (Voraussichtlich)

30. September 2022

Studienabschluss (Voraussichtlich)

30. September 2022

Studienanmeldedaten

Zuerst eingereicht

29. Oktober 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. November 2020

Zuerst gepostet (Tatsächlich)

4. November 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 4.342.082

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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